FDA Relaxes Vaccine Storage Rules to Speed Up Rollout

WASHINGTON – The Food and Drug Administration has relaxed the rules around storage and transportation for some coronavirus vaccines in order to speed up the vaccine rollout.

Frozen vials of Pfizer-BioNTech’s coronavirus vaccine will be allowed to be kept at “conventional temperatures” found in pharmaceutical freezers for up to two weeks, following data provided to the agency by the company. Typically, the FDA demands that undiluted vials be stored in an ultra-low temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF), a written statement from the agency said. 

This will allow for more flexibility, according to the FDA. Health care providers will receive new fact sheets to reflect this update.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said that the data Pfizer provided to the agency proves that the vaccines will remain stable at these less extreme temperatures for the two-week time period.

“The alternative temperature for transportation and storage will help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccines to more sites,” Marks said in a written comment.

In the U.S., 68.27 million doses of the vaccine were administered as of Thursday, Feb. 25, according to data estimates affiliated with Oxford University. An estimated 13.8% of the country, or 46.07 million people, have received at least one dose of a coronavirus vaccine. 

The Pfizer vaccine got an emergency authorization from the FDA in December. An estimate provided by the Department of Health and Human Services reported that the U.S. had purchased about $6 billion worth of Pfizer’s coronavirus vaccine as of Feb. 11.

The FDA has relaxed restrictions and oversights during the coronavirus, which has caused researchers to warn that the situation will need to be revisited after the coronavirus crisis is over to avoid the risk of weakening patient safety in the country. At the moment, however, vaccine rollout is a top priority for the agency.